COMBIVENT® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
COMBIVENT is also the only short-acting bronchodilator that provides 2 different medicines, ipratropium bromide and albuterol sulfate, in a single metered dose inhaler. Studies have shown that, working together, these two medicines do more to open the airways than either medicine can do on its own.
The term "bronchodilator" simply means a medicine that opens (dilates) your airways (bronchi). To help you breathe easier, the two medicines in COMBIVENT work together to help relax the muscles lining your airways. This may help you use the lung capacity you still have, as you continue to manage your COPD over time.
COMBIVENT has been prescribed for over 13 years in the United States. If you've been diagnosed with COPD, ask your doctor if COMBIVENT is right for you.
The dose of COMBIVENT Inhalation Aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Safety and efficacy of additional doses of COMBIVENT Inhalation Aerosol beyond 12 puffs/24 hours have not been studied. Also, safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of COMBIVENT® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol have not been studied. For more information on how to take the correct dosage of COMBIVENT, see pages 16-19 of the Full Prescribing Information and view an instructional video.
Important Safety Information
COMBIVENT Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
COMBIVENT Inhalation Aerosol should not be used in patients who:
COMBIVENT Inhalation Aerosol can cause the narrowing of the airways to get worse (paradoxical bronchospasm) in some patients, which may be life threatening. If this happens, stop taking COMBIVENT Inhalation Aerosol at once and call your doctor or get emergency help.
COMBIVENT Inhalation Aerosol can cause serious allergic reactions. Symptoms include itching, swelling of the face, lips, tongue, or throat (which may cause difficulty in breathing or swallowing), skin rash, hives, bronchospasm (airway narrowing), or anaphylaxis. If you experience any of these symptoms stop taking COMBIVENT Inhalation Aerosol at once and call your doctor or get emergency help.
COMBIVENT Inhalation Aerosol can cause serious heart-related side effects, such as an increase in pulse, blood pressure, and/or related symptoms.
Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Do not use COMBIVENT Inhalation Aerosol more often than your healthcare provider has directed.
Certain medical conditions may increase your risk of side effects.
Tell your healthcare provider about all your conditions and medicines you take, including if you:
Read the step-by-step Patient's Instructions for use before using this medicine.
Remember to vigorously shake your COMBIVENT Inhalation Aerosol for 10 seconds before each use or inhalation.
Do not get the spray into your eyes.
The most common side effects reported with use of COMBIVENT Inhalation Aerosol include bronchitis, infection of the ears, nose, and throat, headache, shortness of breath, and cough.
Please see accompanying full Prescribing Information including Patient Instructions for Use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.